Status:
COMPLETED
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
BrainCells Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depres...
Detailed Description
Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.
Eligibility Criteria
Inclusion
- Subjects will be male and female subjects between the ages of 18 to 65 meeting the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder with a Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) score of \>14 at the Screening and Baseline Visits.
- Female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the Screening Visit.
Exclusion
- Subjects with any other psychiatric Axis-I disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study.
- Subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible.
- Subjects with clinically significant abnormalities on any Screening or Baseline assessments, including laboratory tests, are excluded.
- Subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study.
- Subjects who have used selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of Screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. Concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00705003
Start Date
May 1 2008
End Date
December 1 2008
Last Update
June 18 2014
Active Locations (9)
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1
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
2
Synergy Research Centers
San Diego, California, United States, 91950
3
Atlanta Institute of Medicine & Research, Inc.
Altanta, Georgia, United States, 30328
4
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852